Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode

Atrioventricular Block Clinical Trial

— PRECISE  

Official title:

Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586480
• Other study ID #: RBSY02
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: October 16, 2017
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Observational study on long PR interval using the SafeR mode in bradycardia patients.

Description:

This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months.

• Since implantation, the device is programmed in SafeR mode

• Patient agreed to participate, after having received the appropriate and mandatory information

Exclusion Criteria:

• Patient contraindicated for cardiac pacing, according to current available guidelines

• Permanent atrial fibrillation

• Permanent high-degree AV block

• Patient not available for routine follow-up visits

• Patient already included in another clinical study

• Inability to understand the purpose of the study / refusal to cooperate

• minor age

• Pregnancy

• Life expectancy less than 12 months

• Under guardianship

Related Conditions & MeSH terms

• Atrioventricular Block
• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

Device:
• dual chamber pacemaker with SafeR algorithm
SafeR is an AVB management algorithm: it provides AAI pacing while continuously monitoring AV conduction, it switches to DDD when detecting AVB I, II or III, according to the following criteria: (1) AVB I: 6 long PR intervals, (2) AVB II: 3 blocked atrial events/12 cycles, (3) AVB III: 2 consecutive blocked atrial events. It switches back to AAI mode when needed.

Locations

Country	Name	City	State
France	CH du Pays d'Aix	Aix-en-Provence
France	CH Alençon	Alençon
France	Cabinet Alès	Alès
France	hôpital Sud	Amiens
France	CH Annecy	Annecy
France	hôpital privé Antony	Antony
France	hôpital d'Argenteuil	Argenteuil
France	hôpital St André	Bordeaux
France	CH Bourges	Bourges
France	CHU Brest	Brest
France	Clinique Keraudren	Brest
France	CHU Caen	Caen
France	Clinique des 2 Caps	Calais
France	CH Chartres	Chartres
France	Ch Chaumont	Chaumont
France	Cabinet Cherbourg	Cherbourg
France	HIA Percy	Clamart
France	Hôpital L. Pasteur	Colmar
France	CH Corbeil Essonnes	Corbeil Essonnes
France	Hopital Henri Mondor	Créteil
France	Cabinet Creutzwald	Creutzwald
France	CH Dinan	Dinan
France	CH Douarnenez	Douarnenez
France	CH Evreux	Evreux
France	CMCO Evry	Evry
France	Cabinet Forbach	Forbach
France	CH Forbach	Forbach
France	CH Haguenau	Haguenau
France	CH Helfaut	Helfaut
France	CH Lannion	Lannion
France	CH Le Havre	Le Havre
France	CMCM Le Mans	Le Mans
France	CMC Port Marly	Le Port-Marly
France	CH Lomme	Lomme
France	CH Lorient	Lorient
France	CHU La Timone	Marseille
France	Hôpital Nord	Marseille
France	Clinique Melun	Melun
France	CH Privé Metz	Metz
France	CH Montfermeil	Montfermeil
France	Clinique Montpellier	Montpellier
France	Clinique A. Paré	Nancy
France	NCN Nantes	Nantes
France	CH Orléans	Orléans
France	Cabinet Paris	Paris
France	CH St Joseph	Paris
France	CH Poissy St Germain	Poissy
France	CHU Poitiers	Poitiers
France	Clinique St Hilaire	Rouen
France	CCN St Denis	Saint Denis
France	CH St Nazaire	Saint Nazaire
France	CH Sens	Sens
France	CH St Malo	St Malo
France	CH Basse Terre	Terre Basse	Guadeloupe
France	CH Thionville	Thionville
France	CH Valenciennes	Valenciennes
France	Cabinet Valognes	Valognes
France	CH Villefrance	Villefranche Sur Saone

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1)	This incidence will be measured using PR/AR histograms stored in the device memory	at 12 months